Home Applications 218092 Application 218092
Type ANDA
Sponsor GLENMARK SPECLT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218092-001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 9 · 169 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Esomeprazole Magnesium ESOMEPRAZOLE CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 19fa87e4-8225-4969-9857-1bf43db4427b 2026-07-31 Warnings Name fallback brand name: Esomeprazole Magnesium Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM American Health Packaging 9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb 2026-07-27 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions 71a4fa85-032b-4f50-a2ee-fd9642ae8b15 2026-07-23 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE Rite Aid Corporation 6996642f-a63e-4be9-aefd-0634e9914c2b 2026-07-07 Warnings Name fallback brand name: esomeprazole magnesium Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions 6ad71713-39da-460b-81fc-e5fba103b215 2026-06-23 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack 81f5f7d9-14bb-4804-975e-65d96f91785f 2026-06-18 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM REMEDYREPACK INC. e6e1906f-60be-402f-97f4-6d7bea1a6c08 2026-06-09 Warnings, Adverse reactions Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack fed0e554-7d61-4957-9b91-356f3abc0777 2026-06-08 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole ESOMEPRAZOLE MAGNESIUM Ohm Laboratories Inc. e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c4 2026-06-06 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM 24 HOUR Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Grocery Outlet, Inc. 4467134e-018f-2ad6-e063-6294a90a42bb 2026-06-05 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC d0733d37-cc9c-41ba-9c5f-a0f8bf5a2364 2026-05-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM H-E-B 448bd1ea-baa2-7d6b-e063-6394a90ae5e0 2026-04-29 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM Rising Pharma Holdings, Inc. 2164e1d7-e601-4ce5-be29-0c21c3a5a647 2026-04-16 Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM NCS HealthCare of KY, LLC dba Vangard Labs 28fbfa02-6c7b-4eb1-af24-86825e652326 2026-04-14 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Preferred Pharmaceuticals Inc. a9d05a38-08db-4710-b6f3-20c92ce885d5 2026-04-13 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions b58bfbdb-939e-456e-827d-068e9d808840 2026-04-13 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions 8a8ca4cf-076c-48c9-8613-f5a1bae87a49 2026-04-13 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM AvPAK 4db9f4b8-b6df-f6e9-e063-6294a90a9f60 2026-03-31 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Acid Reducer ESOMEPRAZOLE MAGNESIUM Walgreens 4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc6 2026-03-25 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE HyVee Inc c2308fc8-1549-476d-9769-2991051360ad 2026-03-24 Warnings Name fallback brand name: esomeprazole magnesium